A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00866047
• Other study ID #: SG035-0004
• Secondary ID: 2008-006035-12
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 19, 2009
• Last updated: January 26, 2016
• Start date: March 2009
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: June 2016
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patients with relapsed or refractory systemic ALCL who have previously received front line chemotherapy.

• Documented anaplastic lymphoma kinase (ALK) status.

• Histologically-confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.

• Fluorodeoxyglucose-avid and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.

• Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.

• At US sites, patients greater than or equal to 12 years of age may be enrolled. At non-US sites, patients must be greater than or equal to 18 years of age.

Exclusion Criteria:

• Previous treatment with brentuximab vedotin.

• Previously received an allogeneic transplant.

• Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).

• Known cerebral/meningeal disease.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion

Locations

Country	Name	City	State
Belgium	UZ Gasthuisberg	Leuven
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	B.C Cancer Agency	Vancouver	British Columbia
France	Institut Paoli Calmettes	Marseille
France	Hospital Saint Louis	Paris
France	Centre Henri Becquerel	Rouen
United Kingdom	Christie Hospital NHS	Manchester
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwestern University	Chicago	Illinois
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Baylor Sammons Cancer Center / Texas Oncology	Dallas	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Karmanos Cancer Institute / Wayne State University	Detroit	Michigan
United States	MD Anderson Cancer Center / University of Texas	Houston	Texas
United States	University of Miami Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Stanford University Medical Center	Palo Alto	California
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of Washington	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  France,  United Kingdom, 

References & Publications (1)

Pro B, Advani R, Brice P, Bartlett NL, Rosenblatt JD, Illidge T, Matous J, Ramchandren R, Fanale M, Connors JM, Yang Y, Sievers EL, Kennedy DA, Shustov A. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	B Symptom Resolution	Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.	up to 12 months	No
Primary	Objective Response Rate by Independent Review Group	Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.	up to 12 months	No
Secondary	Complete Remission Rate by Independent Review Group	Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.	up to 12 months	No
Secondary	Duration of Objective Response by Kaplan-Meier Analysis	Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.	up to 17.5 months	No
Secondary	Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis	Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.	up to 17.5 months	No
Secondary	Progression-free Survival by Kaplan-Meier Analysis	Time from start of study treatment to disease progression per independent review group or death due to any cause.	up to 17.5 months	No
Secondary	Overall Survival	Time from start of study treatment to date of death due to any cause.	up to 17.5 months	No
Secondary	Adverse Events by Severity, Seriousness, and Relationship to Treatment	Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.	up to 12 months	Yes
Secondary	Hematology Laboratory Abnormalities >/= Grade 3	Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.	up to 12 months	Yes
Secondary	Chemistry Laboratory Abnormalities >/= Grade 3	Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.	up to 12 months	Yes
Secondary	Area Under the Curve	Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin	3 weeks	No
Secondary	Maximum Serum Concentration	Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin	3 weeks	No
Secondary	Time of Maximum Serum Concentration	Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin	3 weeks	No

External Links

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